PhD System EIA/IFA Software; Model/Catalog Number: 426-0246; The Bio-Rad PhD System is an EIA and IFA processing system

FDA device recall Z-1726-2011 · posted 2011-03-18 · Terminated

Recall details

Recalling firm

Bio-Rad Laboratories, Inc.

Reason for recall

Firm's Correction involves advising customers who have implemented a Laboratory Information System (LIS) that they need to ensure quantitative results have passed all validation criteria prior to reporting patient results. When a patient result fails a Validation Rule, the qualitative result will indicate "INVALID".

Action taken

The firm, Bio-Rad, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated January 20, 2011 to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to review the PhD Worklist Results to verify that all validations have passed and that the quantitative results are valid; to translate (if necessary) the customer letter, add local contacts information, distribute to all active PhD System customers in their region and provide tracking documentation to CSD-RA for all customers who received the customer letter. If you have any questions, contact the Bio-Rad CSD Regulatory Affairs Department at (510) 741-4618.

Root cause

Other

Status

Terminated

Product code

JQW

Quantity affected

650 units

Distribution

Worldwide distribution: USA and countries including:Canada, China, Australia, New Zealand, Czech Republic, France, Hong Kong, India, Italy, Korea, Singapore, Sweden, Taiwan and United Kingdom.

Date initiated

2011-01-20

Date posted

2011-03-18

Date terminated

2011-08-17

Location

Hercules, CA